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Recall Observatory FDA recall evidence

Device product

Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128 CIRCUMCISION TRAY

Z-1051-2020

December 11, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 84530
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1051-2020

Official wording

Reason: Incomplete seals on the sterile package may compromise the sterility

Code information: Lot Numbers: DYNDF1078C CIRCUMCISION TRAY 2019051390 DYNDF1082 CIRCUMCISION TRAY 2019011590 DYNDF1082 CIRCUMCISION TRAY 2018121490 DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP 2019051490 DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP 2018111490 DYNDF1109 TRAY,CIRCUMCISION 2019020690 DYNDF1128 CIRCUMCISION TRAY 2018121490

Distribution pattern: Nationwide Foreign: GHANA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seals on the sterile package may compromise the sterility